Wireless Probe Type Ultrasound Scanner— 510(k) K252709
Substantially EquivalentXuzhou Yongkang Electronic Science Technology Co., Ltd.
FDA 510(k) clearance K252709 for Wireless Probe Type Ultrasound Scanner, Substantially Equivalent on 2026-04-02. Applicant: Xuzhou Yongkang Electronic Science Technology Co., Ltd.. Device class: 2.
Summary
Xuzhou Yongkang Electronic Science Technology's Wireless Probe Type Ultrasound Scanner is filed under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). The name is generic.
Class II, 21 CFR 892.1550. It came in as a Traditional 510(k), and Radiology is both the classification panel and the review panel.
Xuzhou Yongkang Electronic Science Technology filed from Xuzhou, China. Review took 218 calendar days (August 27, 2025 to April 2, 2026).
Clearance details
- Applicant
- Xuzhou Yongkang Electronic Science Technology Co., Ltd.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xuzhou, CN
Recent devices under product code IYN
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from Xuzhou Yongkang Electronic Science Technology Co., Ltd.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.